Quality Head, Global Shared Services and Quality Systems

Job Description

Director - Quality Head, Global Shared Services and Quality Systems

Position Overview

The Quality Head is the senior quality leader responsible and accountable for the overall Pune site Quality organization and contractors under the Quality Shared Services remit. You will be the executive quality representative responsible for maintaining strict compliance with corporate, divisional, and regulatory quality system standards throughout the Pune Site, Global Quality Shared Services (GQSS), and associated and approved contractors. This role reports to the AVP, Global Quality Management Systems, and is a member of the Global QMS Leadership team. This role has significant and impactful responsibility, including executive quality leadership and decision making, regulatory influence and presence, and leadership collaboration with key partners within the company Shared Services Leadership organizations. This role interacts with other key stakeholders, sites, and functions across the network and Sr. Leaders. The Pune Quality Head works with the AVP, QMS, to develop QMS Strategy and Priorities in conjunction with Global QMS Chapter and Topic Owners and is expected to have significant knowledge and a thorough understanding of quality systems and impacted key metrics executed within the Pune site. As an executional arm of the QMS, the Pune Quality Head is a member of the QMS Leadership team and is expected to actively collaborate in the development and ultimate optimization of Quality Strategies, development of sustained and effective QMS topics, and in the creation of digitalized enablement through identified IT means. The Quality Head ensures strategies and processes are in place to ensure inspection readiness. Furthermore, the Quality leader is the primary regulatory contact with overall responsible for health authority inspections at the Pune site.

This role includes the effective leadership of the Pune Quality Unit -Shared Services organization, within both captive and external operations frameworks, covering responsibilities such as talent acquisition, performance management, capability development, audit and inspection readiness, and issue / escalation resolution. Furthermore, the incumbent acts as a subject matter expert in alignment with ICH Q10 and Pharmaceutical Quality System (PQS) guidelines, ensuring rigorous adherence to GMP requirements. The Head ensures complete and timely execution of identified quality systems and proactively monitors KPIs and metrics and forms timely escalations where identified.

This key role is responsible for managing and executing the Pune Site Quality Council and reporting emerging trends and mitigation strategies to Quality Sr. Leadership for complete digestion into the network.

This hybrid role requires in-person attendance at the Pune Global Capability Center for three days each week. Ability to travel to Contractor partners in India and visits to globally including the US as required.

Essential Functions and Responsibilities (Includes, but is not limited to)

The Quality Head, is responsible for

• As the Head., the incumbent will ensure execution and alignment of the Quality organization with all corporate policies and procedures and other division policies and regulatory laws related to the management of quality systems. The Lead will ensure that quality execution is performed under the strict guidelines as defined by law.
• This role is expected to have Senior leadership influence as he / she will interact and deliver Quality Shared Services strategy to GQLT (Global Quality Leadership team), and Divisional Quality Councils, which consists of Sr. Leaders within the division. This role will be responsible for creating sustainable and expandable models for Shared Services adoption as a growth mechanism for this key area. Significant knowledge of Quality Management systems is required as integrated QMS methodology development is necessary for future expansion and growth undefined
• Provide quality and technical knowledge and expertise to the Pune Quality organization and the Pune Shared Services structure, ensuring that Quality is embedded and represented in the overall Shared Services model.
• Perform as the Quality Head, primary liaison, and representative for regulatory inspections and other internal and external audits. The Lead will own and drive inspection readiness strategies, define and create corrective and preventative actions, and ensure mitigation strategies are completed according to the plan and timelines.
• Oversee the GQSS internal auditing program and ensure compliance within the Shared Services Operations model to guarantee alignment with established procedures and service expectations, and maintain a continuous compliance posture
• Responsible for the Pune Quality Plan, which will outline Quality areas of focus. Ensures that plans align with QMS Objectives and Priorities and reflect QMS priorities. Provides frequent status updates accordingly to Senior leaders.
• Actively lead, engage, and monitor Quality team outputs, deliverables, and performance against targets and requirements in established Quality Systems, including but not limited to Compendial Management, Quality Complaints, Incoming Release, Supplier Quality, Quality Agreement, Supplier Change, and Technical Editing.
• Establish and manage Pune Quality Council and deliverables. Deliver metrics and reports to AVP, QMS, senior leadership, and stakeholders. Ensure that escalations are properly mitigated, tracked, and actioned as defined.
• Renders executive quality decisions related to Pune Quality issues, QNs, deviations, deficiencies, and escalations in a succinct and timely manner, ensuring that quality is upheld and business interests are protected.
• Partners with key stakeholders, sites and functions and drives significant Shared Services issues to completion.
• Sponsors and works with Shared Services in the identification of new work as well as efficiency improvement projects
• Owns and operates Pune Quality Hoshin activities, ensuring linkage and integration into Global QMS and overall Shared Services strategies.
• Establishes and manages organizational and capacity forecasts. Works with AVP QMS, TCS partners, and sites / functions to ensure correct resource modeling for business success.
• Support and actively engage with QMS in the development of digitalized approaches to Quality System topics. Support optimization efforts within Quality
• Lead standardization methodologies regarding the implementation and integration of QMS topic adoption. Partner with MPS and QMS partners to arrive at effective and efficient processes.
• Oversee Pune Quality organizational budgets, ensuring fiscal responsibility. Work with the AVP, QMS, and Finance to ensure budgets are within optimization targets.
• Develop and establish Pune Quality as a Quality Center of Excellence.
• Develop training methodologies to sustain current talent and provide opportunities for future growth.
• Foster an attitude of embracing change.
• Where identified, support IT development in digitalization development ( User requirements, UAT, etc.)
• Providing direction and guidance for direct reports and groups under their management, ensures the application of the Performance Management System through establishing clear performance objectives, driving accountability to demonstrate execution excellence, accurately assessing strengths and developmental needs of employees; effectively training and developing all team members in support of employee development and organizational planning processes; recognizing and rewarding team members according to policies.
• Overall responsibility for recruiting and hiring activities for new employees into the GQSS - Delivery Team at the Pune Capability Center (PCC).
• Providing subject matter expertise in alignment with applicable principles in the Pharmaceutical Quality System and ICH Q10
• Ensuring GMP activities in the Delivery Team are consistent with current regulatory expectations.
• Maintaining awareness of evolving industry and regulatory trends associated with quality and compliance.
• Establish and maintain a high-performing organization that provides the highest customer satisfaction level to site, functions, and stakeholders
• Monitoring and constant engagement an appropriate suite of metrics, KPIs, and SLAs in place across all activities in scope for all regions.
• Primary upward interaction is with the direct delivery leads or external service delivery team leads. Largely interacting with peers and senior leadership across management levels in QMS, Quality, Shared Services and External business partners.
• Responsible for governance, coordinating meetings, and overseeing the transition of activities to GQSS in accordance with business requirements and Lean Six Sigma principles adopted by the Merk Manufacturing Division, maintaining Delivery Team procedures, and supporting stakeholders as needed.
• Serving as Quality Lead for internal and business representation; supporting on-site meetings and visits to foster alignment, collaboration, and seamless service delivery.
• Identifying, driving, and implementing continuous improvement initiatives to streamline delivery team processes, enhance efficiency, and reduce operational bottlenecks while ensuring quality and compliance are always maintained.
• Managing quality agreements and overseeing complaint handling processes for divested products to ensure compliance and resolve issues in a timely manner.
• Ensuring that GQSS adheres to all relevant topics within the Company's Quality Management Systems, including implementing and monitoring health check indexes to maintain compliance.
• Responsible for governance, coordinating meetings, and overseeing the transition of activities to GQSS in accordance with business requirements and Lean Six Sigma principles adopted by the Merk Manufacturing Division, maintaining Delivery Team procedures, and supporting stakeholders as needed.

Qualification and Skills Requirements (Includes, but is not limited to)

Qualifications

Required Experience And Skills

Preferred Experience And Skills

Required Skills

Accountability, Accountability, Applied Engineering, Audit Process Evaluations, Cross-Cultural Awareness, GMP Compliance, ICH Q10, Inspection Readiness, Mentoring Staff, Multicultural Leadership, Negotiation, Openness to Change, Organizational Performance Management, People Leadership, Pharmaceutical Quality Assurance, Pharmaceutical Quality Control (QC), Policy Development, Preventive Action, Quality Assurance (QA), Quality Improvement Programs, Quality Management System Improvement, Regulatory Compliance, Regulatory Inspections, Regulatory Reporting, Results-Oriented Leadership + 2 more

Preferred Skills

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Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status

Regular

Relocation

VISA Sponsorship

Travel Requirements

Flexible Work Arrangements

Not Applicable

Shift

Valid Driving License

Hazardous Material(s)

Job Posting End Date

11 / 7 / 2025

Requisition ID R368171

Skills Required

Auditing, Continuous Improvement, Regulatory Compliance, Quality Assurance, Quality Control, Lean Six Sigma